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Panel: Delay treatment for low-risk prostate cancer

Sunday December 11, 2011
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An independent panel convened this week by the National Institutes of Health has concluded that many men with localized, low-risk prostate cancer should be closely monitored, permitting treatment to be delayed until warranted by disease progression.

However, monitoring strategies such as active surveillance have not been uniformly studied, and available data do not yet point to clear follow-up protocols. The panel recommended standardizing definitions and conducting additional studies to clarify which monitoring strategies are most likely to optimize patient outcomes.

"It's clear that many men would benefit from delaying treatment, but there is no consensus on what constitutes observational strategies and what criteria should be used to determine when treatment might ultimately be needed among closely-monitored men," Patricia A. Ganz, MD, the conference panel chairwoman and director of the Division of Cancer Prevention and Control Research at the Jonsson Comprehensive Cancer Center at the University of California, Los Angeles, said in a news release.

Prostate cancer is the most common non-skin cancer in men in the United States. It is estimated that in 2011, approximately 240,000 men will be newly diagnosed with prostate cancer and 33,000 will die of the disease. More than half of these cancers are localized, not aggressive at diagnosis and unlikely to become life-threatening.

However, about 90% of patients receive immediate treatment, such as surgery or radiation therapy. For many of these patients, treatment has substantial short- and long-term side effects, such as diminished sexual function and loss of urinary control; and does not have clear benefits, such as improved survival. Identifying appropriate management strategies for different subgroups of patients is critical to improving survival and reducing the burden of adverse effects.

Two alternatives to immediate treatment of low-risk prostate cancer are observation with and without intent to cure. Observation without intent to cure, sometimes referred to as watchful waiting, is a passive approach, with treatment provided to alleviate symptoms if they develop.

Observation with intent to cure, often referred to as active surveillance, involves proactive patient follow-up in which blood samples, digital rectal exams and repeat prostate biopsies are conducted on a regular schedule, and curative treatment is initiated if the cancer progresses.

The panel identified emerging consensus in the medical community on a definition for low-risk prostate cancer: a prostate-specific antigen level less than 10 ng/mL and a Gleason score of 6 or less. Using this definition, the panel estimated that more than 100,000 men diagnosed with prostate cancer each year would be candidates for active monitoring rather than immediate treatment. However, the panel found that protocols to manage active monitoring still vary widely, hampering the evaluation and comparison of research findings.

"We need to standardize definitions, group patients by their risks, and conduct additional research to determine the best protocols for managing low-risk disease," Ganz said.

The panel further recommended that disease terminology should be refined as a result of changes in the patient population with prostate cancer due to PSA testing. Because of the favorable prognosis of PSA-detected, low-risk prostate cancer, the panel recommended that strong consideration be given to removing the anxiety-provoking term "cancer" for this condition.

The panel also found that clinicians' framing of disease management options is an important factor in patient decision-making. Other influential factors include views of family members, cancer experiences of family and friends, lifestyle priorities and personal philosophy.

Findings from studies in communication sciences and behavioral economics could be applied in clinical settings to promote informed, shared decision-making. While research continues to fill knowledge gaps and develop consensus, the decisions faced by men and their providers following a diagnosis of localized, low-risk prostate cancer should be highly individualized, and include consideration of biological, psychological, social and cultural factors.

Regarding future research, the panel recommended against future federal funding for single-institutional site studies, and emphasized instead the importance of supporting multi-site clinical research studies. The panel also supports the establishment of registry-based cohort studies that collect longitudinal data on active monitoring participants, including clinical and patient-reported outcomes.

An updated version of the panel's draft statement, which incorporates public comments received in an open conference session this morning, is available at http://consensus.nih.gov.


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